Overview of Services
Regulatory Authorities have been accepted Global simultaneous development and global clinical data to bring innovative pharmaceuticals to patients in Japan since 2007. Regulatory Authorities have changed regulations to accelerate pharmaceuticals development in Japan, for instance acceleration of drug review period, Sakigake designation, Conditional approval and so on. Regulatory environment of pharmaceuticals in Japan is significantly changed and be complexed.
Pharma Initiatives Supports helps innovative product development through providing clinical development expertise and regulatory expertise in Japan toward successful commercialization in Japan. In detail, Pharma Initiative Support reviews all relevant data including non-clinical data and provides clinical development strategies and plan after gap analyses. Pharma Initiative Support also supports negotiations with regulatory authorities including PMDA, for instance PMDA consultations, Orphan Drug Designation(ODD), Sakigake Designations. We support an execution of Global clinical studies. We also support Japan-NDA and successful regulatory approvals.
List of Service
consultation, Orphan Drug Designation (ODD), Sakigake Designation, Clinical Trial Notification (CTN) and CMC related submission.
vCommunication in both Japanese and English